Acupuncture and Nausea/Vomiting in Pediatric Patients

NCT ID: NCT01417741

Last Updated: 2019-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group.

1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
2. Control Group: Standard anti-emetic therapy only

This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.

Detailed Description

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Conditions

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Postoperative Vomiting and Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard Therapy Only

Patients will not receive acupuncture. Standard anti-emetic therapy will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Acupuncture Plus Standard Therapy

Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.

Group Type EXPERIMENTAL

Acupuncture Needle

Intervention Type DEVICE

A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist

Interventions

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Acupuncture Needle

A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist

Intervention Type DEVICE

Other Intervention Names

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Seirin Pyonex

Eligibility Criteria

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Inclusion Criteria

* ASA 1 to 3 physical status
* Undergoing Tonsillectomy and/or adenoidectomy
* Consent obtained from Parent/Guardian

Exclusion Criteria

* Taking preoperative steroids, including inhalers
* Taking baseline anti-emetics
* History of motion sickness
* BMI \> 35 (morbid obesity)
* Severe OSA (Apnea/hypopnea Index \> 10)
* Have genetic abnormalities
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Angela Kendrick

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Kendrick, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Christine Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6.

Reference Type BACKGROUND
PMID: 30397904 (View on PubMed)

Other Identifiers

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APOM-7605

Identifier Type: -

Identifier Source: org_study_id

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